US2024058602A1PendingUtilityA1

Electrode leads having multi-application helical nerve cuffs and associated systems and methods

69
Assignee: THE ALFRED E MANN FOUNDATION FOR SCIENT RESEARCHPriority: Jul 9, 2021Filed: Oct 26, 2023Published: Feb 22, 2024
Est. expiryJul 9, 2041(~15 yrs left)· nominal 20-yr term from priority
A61N 1/0556A61N 1/3611A61N 1/36078
69
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Claims

Abstract

An electrode that includes an elongate lead body and a nerve cuff. The nerve cuff may include a biologically compatible, elastic, electrically insulative helical cuff body configured to be disposed around a nerve, and a plurality of electrically conductive contacts carried by the helical cuff body that are spaced from one another.

Claims

exact text as granted — not AI-modified
1 - 15 . (canceled) 
     
     
         16 . A method, comprising:
 placing a helical nerve cuff of an electrode lead on the hypoglossal nerve (HGN) that is configured for placement on either one of the HGN trunk and the branch of the HGN that is responsible for protruding the tongue (HGN GM branch);   applying stimulation energy to the HGN trunk with the helical nerve cuff in instances where the nerve cuff is on the HGN trunk; and   applying stimulation energy to the HGN GM branch with the helical nerve cuff in instances where the nerve cuff is on the HGN GM branch.   
     
     
         17 . A method as claimed in  claim 16 , wherein
 the lead nerve cuff comprises
 a biologically compatible, elastic, electrically insulative cuff body affixed to the distal end of the lead body, the cuff body being configured to be disposed around a nerve, having a pre-set furled helical state that defines an inner lumen, being movable to an unfurled state, and defining a length and a width in the unfurled state that is greater than the length; and 
 a plurality of electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction. 
   
     
     
         18 . A method as claimed in  claim 17 , wherein
 applying stimulation energy to the HGN GM branch with the helical nerve cuff comprises applying stimulation energy to the HGN GM branch with one electrically conductive contact and returning the stimulation energy with another one of the conductive contacts.   
     
     
         19 . A method as claimed in  claim 16 , wherein
 the nerve cuff comprises
 a biologically compatible, elastic, electrically insulative cuff body affixed to the distal end of the lead body, the cuff body being configured to be disposed around a nerve, having a pre-set furled helical state that defines an inner lumen, being movable to an unfurled state, and having a length defining a length direction and a width in the unfurled state, that is greater than the length, defining a width direction; 
 first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction to such an extent that they each extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape; and 
 a plurality of relatively narrow electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts. 
   
     
     
         20 . A method as claimed in  claim 19 , wherein
 applying stimulation energy to the HGN GM branch with the nerve cuff comprises applying stimulation energy to the HGN GM branch with at least one of the relatively narrow electrically conductive contacts and returning the stimulation energy with at least one of the relatively wide electrically conductive contacts.   
     
     
         21 - 23 . (canceled) 
     
     
         24 . An electrode lead, comprising:
 an elongate lead body having a proximal end and a distal end;   a biologically compatible, elastic, electrically insulative cuff body affixed to the distal end of the lead body that has a pre-set furled helical state which defines an inner lumen, that defines a length and a width in the unfurled state that is greater than the length, and that is configured to move from the pre-set furled helical state to a first unfurled helical state on the hypoglossal nerve (HGN) trunk and to move from the pre-set furled helical state to a second unfurled helical state on a branch of the HGN;   a plurality of electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction; and   a plurality of electrical conductors that are electrically connected to the electrically conductive contacts and that extend through the lead body to the proximal end of the lead body.   
     
     
         25 . An electrode lead as claimed in  claim 24 , wherein
 the electrically conductive contacts each define a width and a length that is greater than the width.   
     
     
         26 . An electrode lead as claimed in  claim 25 , wherein
 the cuff body defines a central axis when in the furled, helical state; and   the electrically conductive contacts each define a longitudinal axis that is parallel to cuff body central axis.   
     
     
         27 . An electrode lead as claimed in  claim 25 , wherein
 the electrically conductive contacts comprise generally rectangular electrically conductive contacts.   
     
     
         28 . An electrode lead as claimed in  claim 24 , wherein
 the plurality of electrically conductive contacts comprises at least five electrically conductive contacts.   
     
     
         29 . An electrode lead as claimed in  claim 24 , wherein
 a plurality of lead connector terminals at the proximal end of the lead body that are connected to the plurality of electrical conductors.   
     
     
         30 . An electrode lead as claimed in  claim 24 , wherein
 the HGN branch comprises the branch of the HGN that is responsible for protruding the tongue (HGN GM branch).   
     
     
         31 . A method, comprising:
 after a helical nerve cuff, which is configured for placement on either one of the hypoglossal nerve (HGN) trunk and the branch of the HGN that is responsible for protruding the tongue (HGN GM branch), has been placed on the HGN trunk or on the HGN GM branch,
 applying stimulation energy to the HGN trunk with the helical nerve cuff in instances where the nerve cuff is on the HGN trunk; and 
 applying stimulation energy to the HGN GM branch with the helical nerve cuff in instances where the nerve cuff is on the HGN GM branch. 
   
     
     
         32 . A method as claimed in  claim 31 , wherein
 the helical nerve cuff defines a length and a width in the unfurled state that is greater than the length; and   a plurality of electrically conductive contacts are carried by the nerve cuff and are spaced from one another in the width direction.   
     
     
         33 . A method as claimed in  claim 32 , wherein
 applying stimulation energy to the HGN GM branch with the helical nerve cuff comprises applying stimulation energy to the HGN GM branch with one electrically conductive contact and returning the stimulation energy with another one of the conductive contacts.   
     
     
         34 . A method as claimed in  claim 31 , wherein
 the helical nerve cuff has a length that define a length direction and a width in the unfurled state, that is greater than the length, that defines a width direction;   first and second relatively wide electrically conductive contacts are carried by the nerve cuff, are spaced from one another in the length direction;   a plurality of relatively narrow electrically conductive contacts are carried by the nerve cuff, are spaced from one another in the width direction, and are located between the first and second relatively wide electrically conductive contacts.   
     
     
         35 . A method as claimed in  claim 34 , wherein
 applying stimulation energy to the HGN GM branch with the nerve cuff comprises applying stimulation energy to the HGN GM branch with at least one of the relatively narrow electrically conductive contacts and returning the stimulation energy with at least one of the relatively wide electrically conductive contacts.

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